The largest ever registrational study for a diagnostic product, involving more than 47,000 women shows that the cobas 4800 Human Papillomavirus (HPV) test from Roche, is able to improve the detection of pre-cancerous cells in women whose cervical smears tested normal.
The ATHENA (Addressing THE Need for Advanced) HPV Diagnostics trial demonstrated that more than 1 in 10 women in the trial aged 30 years and older who tested positive for HPV genotypes 16 and/or 18 by the cobas 4800 HPV test had cervical pre-cancer although their Pap1 smear was normal.
The conclusion is that genotypes 16 and 18 if tested positive are high-risk indicators of cervical cancer. The data points to the importance of genotyping to increase the accuracy of assessing the risk of cervical cancer, especially screening for the two high risk HPV genotypes 16 and 18, and underscores the limitations of relying on examining and assessing the appearance of cervical cells under a microscope as is the traditional method.
Cervical cancer causes approximately 1,000 deaths each year in the United Kingdom2. The current system of cervical cancer screening, introduced across the NHS in the late 1980s, is aimed at women aged 20 to 65 years. Women are invited to attend screening every 3 or 5 years depending on age and the system operates on a recall basis if the smear appears abnormal. Persistent HPV infection can lead to the development of pre-cancerous and cancerous cells in the cervix. The new cobas 4800 HPV test from Roche can provide early detection of pre-cancerous changes in the cervix reducing the risk of cervical cancer and thus has the potential to save lives.
“The ATHENA data shows that women who test positive for HPV 16 and/or 18 should be directly referred for closer examination of the cervix by colposcopy,” said Dr Thomas C Wright Jr, M.D. of Columbia University, New York. “Screening for high-risk HPV genotypes provides important additive information to Pap testing, and screening for the two highest risk types, HPV 16 and 18, should be included to provide predictive information about a woman’s risk of having cervical pre-cancer or cancer.”
Findings from the ATHENA clinical trial, also show that women who tested positive for HPV 16 and/or 18 with the cobas 4800 HPV test and who had a normal Pap smear test were at the same risk of having cervical pre-cancer as women who tested positive for any of the 14 high-risk HPV types with an equivocal smear. The latter clinical situation is broadly accepted to carry a risk of pre-cancer that warrants immediate investigation, underscoring again the importance of testing for HPV genotypes 16 and 18 in women with normal Pap smears.
“ATHENA is a landmark trial demonstrating how novel medical diagnostics can address the limitations of cervical cancer screening with Pap smears alone,” said Paul Eros, Director, Molecular Diagnostics for Roche in the UK. “If more women were tested for high-risk HPV subtypes, specifically subtypes 16 and 18, more cervical pre-cancer could be found and treated earlier. This would prevent progression to cancer and ultimately save lives.”
Robert Music, Director of Jo’s Cervical Cancer Trust said: “It seems clear that HPV testing is going to take a more important role in the cervical screening programme and it is good to see that this HPV test has the ability of identifying those women at risk of cervical pre-cancer at an earlier stage with improved detection. In the meantime we must all work hard to increase awareness and remind women of the importance of attending cervical screening when invited. This is evermore important as the most recent screening statistics showed a fall in the number of women taking up their invitation for screening.”
The Roche ATHENA trial for the cobas 4800 HPV test is the largest U.S. based registration study of more than 47,000 women. The trial is designed to answer current medical and scientific questions about the importance of testing for high-risk HPV genotypes in cervical cancer screening and to provide clinical information about the specific HPV genotypes that put women at highest risk for developing cervical cancer.
Persistent infection with human papillomavirus is the principal cause of cervical cancer in women, with HPV implicated in greater than 99% of cervical cancers worldwide. Of the more than 118 different types of HPV, 14 types are currently considered high-risk for the development of cervical cancer and its precursor lesions. HPV types 16 and 18 have been identified as the highest risk genotypes, detected in approximately 70 percent of cervical cancers. Nucleic acid (DNA) testing is a sensitive method for determining the presence of a cervical HPV infection.
As demonstrated in the ATHENA trial, the Roche cobas 4800 HPV test is a new generation of HPV testing which simultaneously detects in one pass, 12 high-risk HPV types (HPV types 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) as a pooled result, as well as HPV genotypes 16 and 18 individually.
Roche launched the cobas 4800 HPV Test with CE Approval in 2009.
Roche
